Safety of mRNA-COVID-19 Vaccines in Patients With Thoracic Cancers.

BACKGROUND: Pivotal trials of COVID-19 vaccines did not include cancer patients with questions remaining in this population. Particularly in patients with thoracic malignancies receiving anticancer treatments, the safety of these vaccines has so far been little investigated. METHODS: This is a prospective trial of patients with thoracic cancer receiving anticancer treatments and COVID-19 vaccines at the Division of Thoracic Oncology of European Institute of Oncology between February and September 2021. RESULTS: A total 207 patients affected by thoracic cancers (199 lung cancers and 8 mesotheliomas) had received Covid-19 vaccines (206 mRNA vaccines and 1 virus-vectored vaccine). The majority of patients had at least one comorbidity (76.3%). They were concomitantly treating with targeted therapy (TT) (45.9%), immunotherapy (IO) (22.7%), and chemotherapy (CT) (14%). A total of 64 AEs (15.6%) were observed after administration of Sars-Cov-2 vaccine. The majority of AEs were grade 1 [G1] (6.3%) and G2 (8.8%), only two events were G3 (0.5%). The median follow-up was 9 months (range 1-22 months), during this follow-up 21 patients (10.1%) had a positive nasal swab, most of the patients were asymptomatic (67%) and the symptomatic ones (33%) had mild symptoms and fewer complications and hospitalizations. CONCLUSIONS: COVID-19 m-RNA vaccines appear to be safe in the cohort of patients with thoracic malignances in active treatment, including those receiving immunotherapy. Considering the high morbidity and mortality associated with COVID-19 in patients with lung cancer receiving active treatments, our study supports the current vaccine prioritization, third and/or fourth dose, of all cancer patients with active treatment.

Auto-immune toxicity of SARS-CoV2 vaccine in patients with thymic epithelial tumours: A prospective analysis from the tyme network

Background: There are many assumptions that raise fears of auto-immune toxicity of SARS-COV-2 vaccine in patients affected by Thymic epithelial tumours (TETs). TETs are associated with paraneoplastic autoimmune disorders and vaccine autoimmune cross reactivity is associated with many syndromes such as Guillain-Barre, multiple sclerosis, demyelinating neuropathies. Moreover, a crossreaction between SARS-Cov-2 anti protein spike antibodies and several tissue proteins has been reported. Material and methods: We are prospectively collecting data on safety and new onset or recurrence of autoimmune disorders in patients with TETs who received SARSCOV- 2 vaccine and are treated in referral centres of the TYME network. Patients with both Thymoma [T] and Thymic carcinoma [TC], with and without pre-existing autoimmune disorders, treated with chemotherapy, immunotherapy, TKI or just in follow up are included in the analysis. Association between epidemiological-clinical factors and risk of general Adverse Events (AEs), immune-related AEs and worsening of autoimmune disorders will be assessed. Results: Preliminary data from the first 20 patients (14 TC and 4 T) suggest that the administration of SARSCOV- 2 vaccines is well tolerated, with no safety signals nor reactivation or new onset of autoimmune diseases observed. Prospective data collection of all TETs patients treated in referral centres of the TYME network is ongoing and will be presented at the time of AIOM congress. Conclusions: Preliminary data suggest that the administration of SARS-COV-2 vaccines is safe and well tolerated in patients affected by TETs. A comprehensive characterization of general and immune-related safety profile of SARSCOV- 2 vaccines in such rare oncological population, enriched for potential risk factors for AEs, is ongoing.

Seroconversion rate after vaccination against COVID-19 in patients with cancer-a systematic review.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has affected >210 million people worldwide. An optimal therapeutic approach for COVID-19 remains uncertain, to date. Since the history of cancer was linked to higher mortality rates due to COVID-19, the establishment of a safe and effective vaccine coverage is crucial in these patients. However, patients with cancer (PsC) were mostly excluded from vaccine candidates' clinical trials. This systematic review aims to investigate the current available evidence about the immunogenicity of COVID-19 vaccines in PsC. PATIENTS AND METHODS: All prospective studies that evaluated the safety and efficacy of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were included, with immunogenicity after the first and the second dose as the primary endpoint, when available. RESULTS: Vaccination against COVID-19 for PsC seems overall safe and immunogenic after well-conducted vaccination schedules. Yet the seroconversion rate remains lower, lagged or both compared to the general population. Patients with hematologic malignancies, especially those receiving B-cell-depleting agents in the past 12 months, are the most at risk of poor seroconversion. CONCLUSION: A tailored approach to vaccination may be proposed to PsC, especially on the basis of the type of malignancy and of the specific oncologic treatments received.

COVID-19 related risk in patients enrolled in early-phase clinical trials

Background: Early phase clinical trials often represent a therapeutical opportunity for cancer patients (pts). However, high logistic commitment is demanded for participation. Here we explore the COVID-19 related risk during the pandemic for pts enrolled in clinical trials compared to pts receiving standard treatments. Methods: We retrospectively assessed the incidence of COVID-19 in pts treated in our Department from March 2020 to April 2021. Pts were divided into two groups;those enrolled in phase I/II clinical trials (A) and those being treated with standard therapies (B). Logistical (telemedicine and drug home-delivery), as well as clinical, characteristics of susceptibility to COVID-19 and number of events (SARS-CoV2 infections) were collected. The number of teleconsultations and COVID-19 events among the two groups were compared through Fisher’s exact test. Results: 115 pts were evaluated: 36 pts (31%) in A and 79 pts (69%) in B. Pts in A were younger, with a median age of 55 years (range 39-77) compared to 62 years (range 31-83) in B. Performance status (PS, ECOG) was similarly distributed: 0 (A 78%, B 83%), 1-2 (A 22%, B 17%). The median of previous treatment was 1 in A (range 0-9) and 2 (range 0-14) in B. The majority of the pts had at least one comorbidity in both groups (A: 72% and B: 83%). None of the pts had pulmonary comorbidity in A and 6% in B. Obesity was similarly distributed (A 11%, B 14%). The mean of monthly scheduled accesses was 1,5 in both groups. However, teleconsultation and delivery of oral cancer treatments at home were given, at least on one occasion, to only 6% of pts in A compared to 43% in B (p<0.01). A total of 15 COVID-19 cases were observed (13%): 8 (22%) in A and 7 (8%) in B. No statistically significant difference was observed (p = 0.068). Conclusions: Pts enrolled in early phase clinical trials had a significantly lower chance to perform teleconsultations compared to pts receiving standard therapy. Even if a trend was observed, they did not have a higher risk of contracting COVID-19. Future pts should then be encouraged to participate, if indicated. Considering the small numbers of pts in our cohorts, the foreseen trend toward a higher infection risk and the subsequent implications should be further explored in larger populations. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: G Curigliano: Financial Interests, Funding: Roche;Financial Interests, Funding: Novartis;Financial Interests, Funding: Lilly;Financial Interests, Funding: Pfizer;Financial Interests, Funding: Seattle Genetics. All other authors have declared no conflicts of interest.

Therapeutic cancer vaccines revamping: technology advancements and pitfalls.

Cancer vaccines (CVs) represent a long-sought therapeutic and prophylactic immunotherapy strategy to obtain antigen (Ag)-specific T-cell responses and potentially achieve long-term clinical benefit. However, historically, most CV clinical trials have resulted in disappointing outcomes, despite promising signs of immunogenicity across most formulations. In the past decade, technological advances regarding vaccine delivery platforms, tools for immunogenomic profiling, and Ag/epitope selection have occurred. Consequently, the ability of CVs to induce tumor-specific and, in some cases, remarkable clinical responses have been observed in early-phase clinical trials. It is notable that the record-breaking speed of vaccine development in response to the coronavirus disease-2019 pandemic mainly relied on manufacturing infrastructures and technological platforms already developed for CVs. In turn, research, clinical data, and infrastructures put in place for the severe acute respiratory syndrome coronavirus 2 pandemic can further speed CV development processes. This review outlines the main technological advancements as well as major issues to tackle in the development of CVs. Possible applications for unmet clinical needs will be described, putting into perspective the future of cancer vaccinology.

Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021.

The 17th St Gallen International Breast Cancer Consensus Conference in 2021 was held virtually, owing to the global COVID-19 pandemic. More than 3300 participants took part in this important bi-annual critical review of the 'state of the art' in the multidisciplinary care of early-stage breast cancer. Seventy-four expert panelists (see Appendix 1) from all continents discussed and commented on the previously elaborated consensus questions, as well as many key questions on early breast cancer diagnosis and treatment asked by the audience. The theme of this year's conference was 'Customizing local and systemic therapies.' A well-organized program of pre-recorded symposia, live panel discussions and real-time panel voting results drew a worldwide audience of thousands, reflecting the far-reaching impact of breast cancer on every continent. The interactive technology platform allowed, for the first time, audience members to ask direct questions to panelists, and to weigh in with their own vote on several key panel questions. A hallmark of this meeting was to focus on customized recommendations for treatment of early-stage breast cancer. There is increasing recognition that the care of a breast cancer patient depends on highly individualized clinical features, including the stage at presentation, the biological subset of breast cancer, the genetic factors that may underlie breast cancer risk, the genomic signatures that inform treatment recommendations, the extent of response before surgery in patients who receive neoadjuvant therapy, and patient preferences. This customized approach to treatment requires integration of clinical care between patients and radiology, pathology, genetics, and surgical, medical and radiation oncology providers. It also requires a dynamic response from clinicians as they encounter accumulating clinical information at the time of diagnosis and then serially with each step in the treatment plan and follow-up, reflecting patient experiences and treatment response.

Igg antibody response in cancer patients and oncology health workers infected with sarscov-2: An Italian, multicenter, prospective study

Background: cancer have been reported to experience severe complications and poor outcomes to severe acute respiratory syndrome coronavirus 2 (SARSCoV-2)-related disease (COVID-19). Anti-SARS-CoV-2 immunoglobulin-G (IgG) can be detected within three weeks after infection. However, scant information is available on the seroconversion rates of patients with cancer and COVID-19. Material: This is a multicenter, observational, prospective study that enrolled patients and oncology health professionals with SARS-CoV-2 infection confirmed by RT-PCR assay, patients and oncology health professionals with clinical or radiological suspicious of infection by SARS-CoV-2, and patients with cancer who are considered at high risk for infection. All subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassett, which is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rate in patients with cancer and healthcare professionals with confirmed or clinically suspected COVID-19. Results: Between March 30 and May 11, 2020, 166 subjects were enrolled in the study. Cancer patients and health workers were 61 (36.7%) and 105 (63.3%), respectively. Seventyfour subjects (44.6%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, while 49 (29.5%) had a clinical suspicious of COVID-19 in absence of RT-PCR confirmation. Median time between symptom onset/ RT-PCR confirmation to serum antibody test was 17 days (IQR, 26). Considering the population with confirmation by RT-PCR, 83.8% was IgG positive. Neither differences in terms of IgG positivity rate nor in median time from SARS-CoV-2 diagnosis to IgG detection were observed between cancer patients and health workers (87.9% vs 80.5%;P=0.39;23.0 vs 28.0 days;P=0.21). Conclusions: Our data indicate that SARS-CoV-2-specific IgG antibody detection does not differ between cancer patients and healthy subjects. Fast test for antibody detection can be complementary to RNA RT-PCR testing for the diagnosis of COVID-19 in this vulnerable patient population.

Seroconversion in patients with cancer and oncology health care workers infected by SARS-CoV-2.

BACKGROUND: Patients with cancer have high risk for severe complications and poor outcome to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease [coronavirus disease 2019 (COVID-19)]. Almost all subjects with COVID-19 develop anti-SARS-CoV-2 immunoglobulin G (IgG) within 3 weeks after infection. No data are available on the seroconversion rates of cancer patients and COVID-19. PATIENTS AND METHODS: We conducted a multicenter, observational, prospective study that enrolled (i) patients and oncology health professionals with SARS-CoV-2 infection confirmed by real-time RT-PCR assays on nasal/pharyngeal swab specimens; (ii) patients and oncology health professionals with clinical or radiological suspicious of infection by SARS-CoV-2; and (iii) patients with cancer who are considered at high risk for infection and eligible for active therapy and/or major surgery. All enrolled subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassette, which is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rate in patients with cancer and oncology health care professionals with confirmed or clinically suspected COVID-19. RESULTS: From 30 March 2020 to 11 May 2020, 166 subjects were enrolled in the study. Among them, cancer patients and health workers were 61 (36.7%) and 105 (63.3%), respectively. Overall, 86 subjects (51.8%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, and 60 (36.2%) had a clinical suspicious of COVID-19. Median time from symptom onset (for cases not confirmed by RT-PCR) or RT-PCR confirmation to serum antibody test was 17 days (interquartile range 26). In the population with confirmed RT-PCR, 83.8% of cases were IgG positive. No difference in IgG positivity was observed between cancer patients and health workers (87.9% versus 80.5%; P = 0.39). CONCLUSIONS: Our data indicate that SARS-CoV-2-specific IgG antibody detection do not differ between cancer patients and healthy subjects.

Anti-SARS-CoV-2 antibody response in patients with cancer and oncology healthcare workers: A multicenter, prospective study

Background: Poor outcomes for patients with cancer and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease (COVID-19) have been reported so far. Although anti-SARS-CoV-2 IgG response is usually detectable within three weeks after infection, limited information on the seroconversion rate of patients with cancer infected by SARS-CoV-2 is available. Methods: This is a multicenter, observational, prospective study that included patients and oncology healthcare workers (HCWs) with SARS-CoV-2 infection confirmed by RT-PCR or clinical/radiological suspicious of infection as well as patients with cancer who are considered at high risk for infection. All subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassett for the fast detection of IgG and IgM antibodies against SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rates by qualitative assay in patients with cancer and HCWs with confirmed or clinically suspected COVID-19. Results: At first interim analysis, 166 subjects were enrolled in the study. Cancer patients and HCWs were 61 (36.7%) and 105 (63.3%), respectively. HCWs were younger than patients with cancer (median age 41 vs 62 years;P<0.001). Eighty-six subjects (51.8%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, while forty-nine (29.5%) had a clinical suspicious of COVID-19 in absence of RT-PCR confirmation. In patients with RT-PCR-confirmed SARS-CoV-2 infection, 62 (83.8%) were IgG-positive. Neither differences in terms of IgG positivity (87.9% vs 80.5%;P=0.39) nor in median time from COVID-19 diagnosis to IgG detection (23.0 vs 28.0 days;P=0.21) were found between patients with cancer and HCWs. Conclusions: Our data show that SARS-CoV-2-specific IgG antibody response is not different between cancer patients and healthy subjects. Qualitative rapid test for antibody detection represents an useful support to RNA RT-PCR testing for the diagnosis of COVID-19 in high-risk populations, including patients with cancer. Legal entity responsible for the study: Istituto Europeo di Oncologia IRCCS. Funding: This work was partially supported by the Italian Ministry of Health with Ricerca Corrente and 5x1000 funds. MEDnoTE srl (Spin-off of University of Trieste) supported the present study by providing the rapid test used for anti-SARS-CoV-2 antibody detection. Disclosure: D.G. Generali: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis, Pfizer, Lilly. G. Curigliano: Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy: Mylan, Daichii Sankyo;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly, Pfizer, Merck, Foundation Medicine, Samsung, Celltrion;Advisory/Consultancy, Speaker Bureau/Expert testimony: Seattle Genetics, Nanostring;Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Speaker Bureau/Expert testimony: Novartis, BMS;Honoraria (self): Ellipsis. All other authors have declared no conflicts of interest.

Expected medium and long term impact of the COVID-19 outbreak in oncology

Background: The ongoing SARS-CoV-2 pandemic and ensuing coronavirus disease (COVID-19) is challenging cancer care and services worldwide. Methods: A 95 items survey was distributed worldwide by 20 oncologists from 10 of the most affected countries in order to evaluate the impact on organization of oncological care. Results: 109 representatives from oncology centers in 18 countries (62.4% academic hospitals) filled out the survey (June 17 – July 14, 2020). A swab or gargle test is systematically performed before day care unit or overnight stay admissions in 27.5% and 58.7% of the centers, respectively. A local registry (64.2%) and systematic tracing (77.1%) of infected patients was organized in many centers. Treatment modalities mostly affected by the pandemic (cancellation/delay) were surgery (44.1%) and chemotherapy (25.7%). Earlier cessation of palliative treatment was observed in 32.1% of centers, and 64.2 % of participants agree that under-treatment is a major concern. At the pandemic peak, teleconsultations were performed for follow-up (94.5%), for oral therapy (92.7%), but also for patients receiving immunotherapy (57.8%) or chemotherapy (55%). Approximately 82% of participants estimate that they will continue to use telemedicine. Most participants reported more frequent use of virtual tumor boards (82%) and oncological team meetings (92%), but 45% disagree that virtual meetings are an acceptable alternative to live international meetings. Although 60.9% report reduced clinical activity during the pandemic peak, only 28.4% had an increased scientific activity. Only 18% of participants estimate that their well-being will not recover to previous levels by the end of the year;63% indicate easily accessible psychological support for caregivers, but only 10% used or planned to use it. All clinical trial activities are or will soon be reactivated in 72.5% of the centers. Major study protocol violations/deviations were observed in 27.5% and significant reductions of clinical trial activities are expected by 37% of centers this year. Conclusions: COVID-19 has a major impact on organization of patient care, well-being of caregivers, continued medical education and clinical trial activities in oncology. Legal entity responsible for the study: The authors. Funding: Fondation Léon Fredericq. Disclosure: G. Jerusalem: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly;Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen;Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca;Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo;Advisory/Consultancy: AbbVie;Travel/Accommodation/Expenses: MedImmune;Travel/Accommodation/Expenses: Merck KGaA. G. Curigliano: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Seattle Genetics;Speaker Bureau/Expert testimony, Writing engagement: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony: Foundation Medicine;Advisory/Consultancy, Speaker Bureau/Expert testimony: Samsung;Advisory/Consultancy, Speaker Bureau/Expert testimony: Celltrion;Leadership role, Scientific Affairs Group: Ellipsis;Speaker Bureau/Expert testimony, Writing engagement: BMS;Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy: Mylan. M. Campone: Honoraria (self), Advisory/Consultancy: GT1;Honoraria (institution), Advisory/Consultancy: Sanofi;Honoraria (institution), Advisory/Consultancy: Pierre-Favre;Honoraria (institution), Advisory/Consultancy: AstraZeneca;Honoraria (institution), Advisory/Consultancy: Servi r;Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Honoraria (institution), Advisory/Consultancy: AbbVie;Honoraria (institution), Advisory/Consultancy: Accord;Honoraria (institution), Advisory/Consultancy: Pfizer;Speaker Bureau/Expert testimony: Lilly. M. Martin: Advisory/Consultancy, Research grant/Funding (institution): Roche;Advisory/Consultancy, Research grant/Funding (institution): Novartis;Advisory/Consultancy, Research grant/Funding (institution): Puma;Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: Amgen;Advisory/Consultancy: Taiho Oncology;Advisory/Consultancy: Daichii Sankyo;Advisory/Consultancy: PharmaMar;Advisory/Consultancy: Eli Lilly;Advisory/Consultancy: Pfizer. M. Cristofanilli: Advisory/Consultancy: CytoDyn;Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer;Advisory/Consultancy: Lilly;Advisory/Consultancy: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Foundation Medicine;Advisory/Consultancy: G1 Therapeutics;Advisory/Consultancy: Sermionexx;Advisory/Consultancy: Genentch. L. Pusztai: Honoraria (self), Research grant/Funding (institution), Clinical trial support: Merck;Honoraria (self), Research grant/Funding (institution), Clinical trial support: AstraZeneca;Honoraria (self), Research grant/Funding (institution), Clinical trial support: Seattle Genetics;Honoraria (self): Novartis;Honoraria (self), Research grant/Funding (institution), Clinical trial support: Roche Genentech;Honoraria (self): Eisai;Honoraria (self): Daiichi;Honoraria (self): Syndax;Honoraria (self): Immunomedics. R. Bartsch: Advisory/Consultancy: Accord;Honoraria (self): AstraZeneca;Advisory/Consultancy, Research grant/Funding (institution): Daiichi;Advisory/Consultancy, Travel/Accommodation/Expenses: Eli-Lilly;Advisory/Consultancy, Travel/Accommodation/Expenses: MSD;Advisory/Consultancy, Research grant/Funding (institution): Novartis;Advisory/Consultancy, Research grant/Funding (institution): Roche;Advisory/Consultancy: Puma;Advisory/Consultancy: Pierre-Favre;Advisory/Consultancy: Sandoz;Advisory/Consultancy: Eisai. M. Tagliamento: Travel/Accommodation/Expenses: Roche;Travel/Accommodation/Expenses: Bristol-Myers Squibb;Travel/Accommodation/Expenses: AstraZeneca;Travel/Accommodation/Expenses: Takeda;Travel/Accommodation/Expenses: Novartis;Travel/Accommodation/Expenses: Amgen. J. Cortés: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy: Celgene;Advisory/Consultancy: Cellestia;Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca;Advisory/Consultancy: Biothera Pharmaceutical;Advisory/Consultancy: Merus;Advisory/Consultancy: Seattle Genetics;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo;Advisory/Consultancy: Erytech;Advisory/Consultancy: Athenex + Polyphor;Advisory/Consultancy, Shareholder/Stockholder/Stock options: MedSIR;Honoraria (self), Advisory/Consultancy: Lilly;Advisory/Consultancy: Servier;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp Dome;Advisory/Consultancy: GSK;Advisory/Consultancy: Leuko;Advisory/Consultancy: Bioasis;Advisory/Consultancy: Clovis Oncology;Advisory/Consultancy: Boehringer Ingelheim;Honoraria (self), Travel/Accommodation/Expenses: Novartis;Honoraria (self), Travel/Accommodation/Expenses: Eisai;Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Honoraria (self): Samsung Bioepis;Research grant/Funding (institution): Ariad Pharmaceuticals;Research grant/Funding (institution): Baxalta GMBH/Servier Affaires;Research grant/Funding (institution): Bayer Healthcare;Research grant/Funding (institution): F. Hoffmann-La Roche;Research grant/Funding (institution): Guardanth Health;Research grant/Funding (institution): Piqur THerapeutics;Research grant/Funding (institution): Puma C;Research grant/ unding (institution): Queen Mary University of London. E.M. Ciruelos: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer. H.S. Rugo: Research grant/Funding (institution): Eisai;Research grant/Funding (institution): Genentech;Research grant/Funding (institution): Lilly;Research grant/Funding (institution), Travel/Accommodation/Expenses: MacroGenics;Research grant/Funding (institution): Merck;Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Research grant/Funding (institution): Obi Pharma;Research grant/Funding (institution): Odonate Therapeutics;Research grant/Funding (institution): Immunomedics;Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi-Sankyo;Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy: Samsung;Advisory/Consultancy: Celtrion;Travel/Accommodation/Expenses: Mylan;Travel/Accommodation/Expenses: AstraZeneca. All other authors have declared no conflicts of interest.

The impact of COVID-19 pandemic on cancer care: A global collaborative study

Background: COVID-19 pandemic impacted healthcare systems globally and resulted in the interruption of usual care in many healthcare facilities exposing vulnerable cancer patients to significant risks. Our study aimed to evaluate the impact of this pandemic on cancer care worldwide. Methods: We conducted a cross-sectional study using validated electronic questionnaire of 51 items via SurveyMonkey©. The tool was distributed to leaders in oncology centers worldwide. The questionnaire obtained information on the capacity and services offered at these centers, magnitude of interruption of care, reasons for interruption, challenges faced, interventions implemented, and the estimation of patient harm during the pandemic. Results: 356 centers from 54 countries across six continents participated between April 21 and May 8, 2020. These centers serve about 700,000 new cancer patients a year. Most of them (88%) reported facing challenges in providing care during the pandemic. 54% and 45% of centers reported cases of COVID-19 infection among their patients and staff, respectively. Although 51% reduced services as part of a preemptive strategy, other common reasons included overwhelmed system (20%), lack of personal protective equipment (19%), staff shortage (18%), and restricted access to medications (9.7%). Missing at least one cycle of therapy by more than 10% of patients was reported in 46% of the centers. Most centers implemented virtual clinics (83.6%) and virtual tumor boards (93%) and participants believed these will persist beyond the pandemic (55.5% and 60%, respectively). Centers performed routine tests in laboratories near patients’ homes (76%) and shipped medications to patients (68.6%). Participants reported patients’ exposure to harm from interruption of cancer-specific care (36.5%) and non-cancer related care (39%) with some centers estimating up to 80% of their patients exposed to some harm. Only 16% of the centers reported services are back to baseline at the time of completing the survey. Conclusions: The detrimental impact of COVID-19 pandemic on cancer care is widespread with varying magnitude among centers worldwide. Further research to assess this impact at the patient level is required. A “new normal” of cancer care emerged with emphasis on telehealth and care delivery closer to home. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: A.R. Jazieh: Research grant/Funding (self): MSD. C.D. Rolfo: Speaker Bureau/Expert testimony: AstraZeneca;Advisory/Consultancy: Inivata;Archer;MD Serono;Mylan;Oncompass;Honoraria (self): Elsevier. All other authors have declared no conflicts of interest.

Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus.

We established an international consortium to review and discuss relevant clinical evidence in order to develop expert consensus statements related to cancer management during the severe acute respiratory syndrome coronavirus 2-related disease (COVID-19) pandemic. The steering committee prepared 10 working packages addressing significant clinical questions from diagnosis to surgery. During a virtual consensus meeting of 62 global experts and one patient advocate, led by the European Society for Medical Oncology, statements were discussed, amended and voted upon. When consensus could not be reached, the panel revised statements until a consensus was reached. Overall, the expert panel agreed on 28 consensus statements that can be used to overcome many of the clinical and technical areas of uncertainty ranging from diagnosis to therapeutic planning and treatment during the COVID-19 pandemic.